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Customized Solutions

Process Validation Solutions

 Long before any pharmaceuticals or medical devices reach the patients or the healthcare professionals who depend on them, the systems, equipment, processes, and methods behind developing, producing, and testing them must be validated to ensure they function as intended. 

Compliance Solutions

 ​Regulatory compliance requirements extend throughout the full product life cycle. Violations of regulatory compliance regulations often results in legal challenges. Starting  from development through approval, manufacturing, launch, and required post market reporting, STS will help develop  strategy in place to help manage the regulatory compliance. 

Pre-Clinical Solutions

 Preclinical studies during the early phases of development plays an essential part in the approval of any product. STS Pre-clinical services help investigators  to accelerate new medical product development in the academic setting and enhance the opportunities for their commercialization. STS guides the investigator to assemble a nonclinical data package (e.g., pharmacology, pharmacokinetics, and product characterization) that will support the regulatory requirements for initiation of clinical trials. 

Quality Management

 Quality management is a multidimensional issue, covering more than just verification that a finished product meets certain expectations. 




RISK management

 Product manufacturing inevitably faces ongoing risks to finances, products, data, equipment, property, and personnel. 




Data management

 Efficient collecting, transferring, and managing of data during a preclinical and clinical trial is crucial to advance the development process 




Idea-to-product

 Aid in turning your invention idea into marketable product.  





product-to-market

 Aid in introducing product to global market and assist in launching product on global platforms 



market analysis

 With globalization, future trends and market value of the product needs in-depth analysis for business growth 





digitalization

From mobile medical apps and software that support the clinical decisions doctors make every day to artificial intelligence and machine learning, digital technology has been driving a revolution in health care.  STS digitalization experts can help you with your digital health products.

Automation

Automation of regulatory procedures can intensely improve the efficiency and productivity of manufacturers. Process automation can not only save time but also ensure that the product is manufactured in consistent manner with utmost reproducibility. 




Training

 Our training goal is to maximize your potential and enhance your performance to help you reach your goals.  STS will work with you during all phases of the career development process and provides career development resources at any junction of your career, be it early career development or intermediate skill enrichment.